If you are the
recipient of a Stryker Rejuvenate or ABGII hip implant then perhaps you have
experienced problems related to the implant. Like other metal-on-metal hip
implants, the Rejuvenate and ABGII have the potential of causing metallosis
even though the design calls for a ceramic head rather than a metal one.
Stryker issued a recall of the both implants this past July, 2012 after first
issuing an Urgent Field Safety Notice to hospitals and physicians in the prior April.
This notice cited the potential of fretting and corrosion at the neck juncture
as well as the risk of metal ion release.
While there is
not the same level of surface area as the all-metal implants, the corrosion
which can occur in the Stryker Rejuvenate and Stryker ABGII can nonetheless
lead to metallosis. In addition to the neck juncture which can result in corrosion,
there are metal trunnions located at either end of the neck which allow the
component to snap into the stem on one end and the acetabular
cup on the other. Body fluids can become trapped under these trunnions, leading
to further corrosion.
In some cases,
recipients of the Rejuvenate or ABGII could receive a letter from Stryker in
response to an issue with the implant reported to Stryker by the patient or the
patient’s physician, or by the patient’s treatment facility. This letter, which
states it will initiate a Product Experience Report—or PER—generally appears
fairly mild, thanking the patient or doctor for submitting their Stryker hip implant
concerns. The letter also likely indicates that a PER will be put together for
the patient and that the patient must only sign the included “Authorization to
Use or Disclose Health Information”, allowing Stryker access to their medical
records in order to fully investigate the issue. If you are in receipt of such
a letter from Stryker, be very cautious regarding signing the form which gives
Stryker access to your medical records.
DePuy’s Broadspire Letter
When DePuy’s
ASR implant was recalled and lawsuits began being filed, the company contracted
with Broadspire to issue a letter to implant recipients which essentially
offered to pay revision surgery costs to all those who met the criteria. In
return, the patient essentially signed away their right to file suit against
DePuy down the line, agreed to allow DePuy access to their medical records, and
agreed to give DePuyany implant removed during revision surgery. Many implant
recipients gratefully signed the letter, glad to have their revision surgery
and related medical expenses paid for. Unfortunately, it turned out to be much
less straightforward than promised.
Many implant
recipients were painted unfavorably based on their medical records. Company
officials were able to point to a myriad of reasons—other than the actual
implant—which were responsible for the health problems being experienced.
Perhaps the patient was overweight, had diabetes, was very active or had suffered
some sort of injury in the past. The most innocent health issue was used to
deny deserving patients both their day in court as well as medical expenses
related to the implant.
How Does the Broadspire Letter Relate to
Stryker’s PER Letter?
Now Stryker’s
PER has been a quality control mechanism utilized since before its Rejuvenate
and ABGII recalls. But while the PER Letter is not offering to pay for revision
surgery or implant-related costs at this point, is not yet asking patients to
waive their rights to future recovery and is not requesting that implants which
are removed during revision surgery be turned over to them (as the Broadspire
Letter does), there are nonetheless potential negative consequences associated
with allowing Stryker access to your medical records. Should you allow Stryker
to access your medical records, they may first identify you as a potential
claimant. They may then use your medical records to lay the blame of your
health issues on anything other than their recalled hip implant.
Health Risks of Metallosis
When corrosion
of the Rejuvenate or ABGII occurs in recipients of the implant, microscopic
ions of cobalt and chromium are released into the patient’s body. Should they
become lodged in surrounding tissues, the patient may experience serious
inflammation, tissue necrosis and bone loss. Chronic pain is likely, varying
from moderate to severe. The hip implant can loosen, leading to total failure
and the necessity of revision surgery.
Should the toxic metals enter the bloodstream, they can begin to
steadily build up as the corrosion continues. Although each person will respond
differently to levels of cobalt and chromium in their body, almost any amount
is too much.
Cardiovascular
issues, neurological problems, kidney problems and thyroid issues are all possible
results from the buildup of cobalt and chromium. Further, vision and hearing
loss, gastrointestinal disorders, skin problems, pseudo-tumors, balance issues
and loss of memory can also occur as the levels of cobalt and chromium continue
to accumulate. Once the implant is removed from the body it could take a
considerable amount of time for all the metals to be flushed from the body,
and, in some cases, the effects are not reversible. The FDA has received over
60 reports of adverse effects from the Stryker Rejuvenate and Stryker ABGII and
many of the implants failed within a year and a half.
A further
issue associated with the PER letter from Stryker relates to the fact that the
former CEO of DePuy—who was in charge during the aftermath of the ASR recall—is
now working for Stryker. David Floyd left DePuy following the ASR recall to go
to Ortho Workx. According to the Houston Chronicle, only last month Floyd left
Ortho Workx to be head of Stryker’s orthopedic unit. It is not hard to imagine,
therefore, that the mild PER letter could eventually lead to a letter similar
to the Broadspire letter being sent to recipients of the Stryker Rejuvenate and
Stryker ABGII. Many people trusted DePuy to take care of their medical expenses
related to the implant based on the Broadspire letter when in fact the released
medical records were later used to deny those expenses.
Should You Receive a Stryker PER Letter,
Exercise Caution?
It is rarely a
good idea to release your medical records to a company who could potentially
use those records against you in the future. You also don’t want to threaten your
right to a future lawsuit should your recalled Stryker hip implant fail,
leaving you to deal with exorbitant medical expenses related to a revision
surgery. Revision surgery for the Rejuvenate and ABGII are considered to be
much riskier than for other metal-on-metal hip implants because the stem of
Stryker’s implants is buried deeply within the femur.
When removed,
the bones can shatter or fracture, leading to further surgical procedures and,
in some cases, permanent disability. If you have received (or receive in the
future) a PER letter from Stryker, consider your options very carefully and use
your best judgment in the determination of whether or not you want to allow Stryker
access to your medical records. The preservation of a potential claim against
Stryker could be at stake.
